Z-0771-2024 Class II Ongoing
FDA device recall Z-0771-2024 was initiated by Getinge Usa Sales Inc on November 8, 2023 and is designated Class II. Reason for recall: A potential for a light system to fall in the operating room. The recall status is ongoing. Affected quantity: 236793 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- November 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236793 units in total
Product Description
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Reason for Recall
A potential for a light system to fall in the operating room.
Distribution Pattern
US Nationwide. Global Distribution.
Code Information
All systems affected